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D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer

A Phase I/II Trial of D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer - The AIO-MEFOX Trial (AIO-KRK-0119)

NCT05212012•AIO-Studien-gGmbH

View on ClinicalTrials.gov

Summary

This is a phase I/II-trial with D,L-methadone and mFOLFOX6 in the treatment of patients with histologically confirmed chemo-refractory colorectal carcinoma. The aim of the phase-I trial is to evaluate the toxicity-profile and the dose-limiting toxicity of D,L-methadone combined with mFOLFOX6. Furthermore, to estimate the maximum tolerated dose and the recommended dose for phase-II-trial in the treatment of patients with histologically confirmed colorectal carcinoma not amenable to or progressing while having received all standard therapies. The primary endpoint of the randomized phase-II study is to determine the disease control rate 12 weeks after randomization of patients with histologically confirmed advanced colorectal carcinoma upon treatment with D,L methadone plus mFOLFOX6 versus mFOLFOX6 alone. Overall response rate according to RECIST1.1, progression free survival (PFS), overall survival (OS), quality of life (QoL) according to the EORTC QLQc30 questionnaire, patient-reported outcomes and safety will be evaluated as secondary objectives.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Advanced, histologically confirmed, metastatic colorectal carcinoma not suitable for resection and chemorefractory or Previously employed chemotherapy regimens and agents should comprise the following: Fluoropyrimidines, oxaliplatin, irinotecan, antiangiogenic agents (bevacizumab, aflibercept or ramucirumab), anti-EFGR-mAbs (in case of all-Ras-wildtype and left-sided primary tumor) and Trifluridin/Tipiracil (TAS102)
•Microsatellite stable subset (MSS) of colorectal cancer
•Prior antineoplastic therapy or radiochemotherapy is allowed up to two weeks prior to start of the study medication. However, for the phase II part of the trial, failure of this strategy must be confirmed. In case of prior radiotherapy/radiochemotherapy the target lesion used for tumor evaluation must not be in the radiation field.
•There must be an oxaliplatin free period of at least 6 months prior to start of the study medication.
•No polyneuropathy of \> grade 1
•Tumor-related ECOG performance status 0-2
•Anticipated life expectancy ≥ 12 weeks
•Creatinine clearance ≥ 30 ml/min
•Serum total bilirubin level ≤ 3 x ULN.
•ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of liver metastasis (established after adequate biliary drainage)
+6 more criteria

Exclusion Criteria

•Microsatellite unstable CRC (MSIhigh)
•Chronic infectious diseases, immune deficiency syndromes
•Polyneuropathy \>grade I according to CTCAE V4.03
•Premalignant hematologic disorders, e.g. myelodysplastic syndrome
•Disability to understand and sign written informed consent document
•Past or current history of malignancies except for the indication under this study and curatively treated:
•* Basal and squamous cell carcinoma of the skin
•* In-situ carcinoma of the cervix
•* Other malignant disease without recurrence after at least 3 years of follow-up
•Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
+15 more criteria

Locations (3)

Universitätsklinikum Hamburg Eppendorf - II. Med.

Hamburg, Germany

Stauferklinikum Schwäbisch Gmünd

Mutlangen, Germany

Universitätsklinikum Ulm - Innere Med. I

Ulm, Germany

Key Dates

Start Date

February 17, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 3, 2025

Enrollment

ACTUAL participants

Conditions

Chemo-refractory Colorectal Carcinoma

Interventions

Maximum tolerated dose, MTD: D,L-methadone hydrochloride (Methasan® 10 mg/ml)

DRUG